The Medicines Company
) recently announced the presentation of data on its antibiotic
candidate, oritavancin, at the 53rd Interscience Conference on
Antimicrobial Agents and Chemotherapy (ICAAC). Oritavancin is
being evaluated for the treatment of acute bacterial skin and
skin structure infections (ABSSSI) caused by susceptible
gram-positive bacteria, including methicillin-resistant
staphylococcus aureus (MRSA).
Data was presented from the phase III SOLO program comprising
the SOLO I and SOLO II studies. Results showed that a single 1200
mg dose of oritavancin was non inferior to 7 to 10 days of
) Vancocin (vancomycin) in treating ABSSSI caused by
gram-positive pathogens including MRSA.
While The Medicines Co. had announced results from the SOLO II
study in Jul 2013, SOLO I results were released last year in
December. Combined SOLO results showed that microbiologically
confirmed MRSA patients on oritavancin achieved the FDA-proposed
endpoint of ≥20% reduction of lesion area at Early Clinical
Evaluation (ECE) more frequently than Vancocin-treated
With the SOLO program reporting positive data, The Medicines
Co. will file for U.S. and EU approval in the fourth quarter of
2013 and the first half of 2014, respectively. The Medicines Co.
is also exploring the possibility of developing oritavancin for
additional indications like clostridium difficile, prosthetic
joint infections, anthrax and other gram-positive bacterial
Oritavancin's single dosing regimen and safety profile could
give it an edge over currently available intravenous treatments
which require multiple-day dosing and are associated with
treatment-limiting adverse events.
The Medicines Co. currently carries a Zacks Rank #3 (Hold).
Currently, companies that look well-positioned include
). Both are Zacks Rank #1 (Strong Buy) stocks.
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